It is estimated that there over 4,000,000 cases of canine cancer diagnosed in the United States of America each year, of which up to one quarter are represented by canine lymphoma. While the total number of dogs that are treated for lymphoma is not clear, a conservative estimate is that in the United States of America alone approximately 7,000-10,000 dogs per year are treated with chemotherapy (typically using protocols that include doxorubicin) for lymphoma. The typical cost of this treatment is about $4,000-6,000, resulting in an annual treatment cost in the USA of approximately $30,000,000-$60,000,000.
The vast majority of owners do not treat their dogs for their lymphoma, however. Discussions with veterinary oncologists suggest that one reason for this is the cost of treatment, while another common reason is the “cost versus unknown outcome”. A widely used treatment protocol termed “UW-25” is reported to provide up to 90% chance of remission for a median survival of nine months. However, individual remissions can vary from weeks to years, and as a result, the availability of a test that can more accurately predict the duration of remission following therapy would be of great value to clinicians and clients in the decision process.
If such a predictive test were available, many more owners might consider treating their dog for lymphoma, particularly if they were given an accurate predictor of how their dog will respond to therapy, assuming that such a test could be offered at an affordable level of expense. While some owners still would not be in a position to afford the cost of chemotherapy, regardless of possible outcome, there is likely a large number who would be more willing to treat their dogs if they knew that the chance of their pet surviving for, For example, at least a year, was 90-95% or greater. On this basis, the number of candidates that could be considered as a potential beneficiary of a test that would predict time to remission might be substantially higher than 10,000 per year.
Lymphoma is the most common life-threatening cancer in dogs, accounting for up to 24% of all canine malignancies and over 80% of all canine hematopoietic cancers. As in humans, canine lymphoma is a spontaneous malignancy and is generally a disease of middle-aged to older dogs that affects a wide range of breeds.
Untreated cases of canine lymphoma rarely survive beyond three months post-diagnosis, but a large proportion (up to 90%) of canine lymphomas are generally responsive to standards of care using either single agent or multi-agent chemotherapy, increasing both the length and quality of an affected dog's life. Among treated cases receiving the same initial diagnosis, however, there is considerable variation in the extent of response to therapy and overall survival time. This indicates that there is a need to develop more refined modes of classification that are of prognostic significance. At the present time, however, there is no available approach to accurately predict response to chemotherapy of dogs diagnosed with lymphoma.
The PATHVYSION™ HER-2 DNA Probe Kit (Abbott Laboratories, Des Plaines, Ill., United States of America) is designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. The kit uses the relative copy number of the HER-2 gene to help predict time to remission of the breast cancer.
Described herein is a novel test has been developed for a cancer. The test provides clinicians with the ability to predict with a degree of statistical probability how long before their lymphoma patients will likely enter first remission when treated with a standard of care therapy. There is immediate significance to the veterinary market and predictive potential of the chromosomal regions defined in canine lymphoma in human cancer patients. These regions can inform human oncologists of the likely remission period for human cancer patients.